—Urges Increased Local Production of Medical Devices

By Chioma Obinna

LAGOS — The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the World Health Organization (WHO) pre-qualification of AFRI Medical Manufacturing and Supplies Limited’s 0.5ml auto-disabled syringes, marking the first time a Nigerian company—and indeed the first in West and Central Africa—has achieved such certification for syringes.

Speaking during a press briefing at NAFDAC’s Isolo office in Lagos, the agency’s Director General, Prof. Mojisola Adeyeye, described the achievement as a testament to the success of NAFDAC’s strategies to promote local manufacturing of high-quality medical products.

“This feat was not achieved overnight,” Adeyeye stated. “It is the result of a rigorous process, heavy investment by AFRI Medical, and consistent guidance and support from NAFDAC. Today, their product is on the WHO list of pre-qualified medical devices, making it eligible for international procurement by UNICEF and other global bodies.”

Adeyeye highlighted that the WHO pre-qualification allows AFRI Medical to export its syringes globally, enhancing Nigeria’s presence in the international medical device market. She noted that the milestone aligns with the Federal Government’s industrialization agenda and President Bola Ahmed Tinubu’s policy to strengthen the domestic economy through local production.

“In keeping with our vision to be a world-class regulator, NAFDAC has embraced global best practices in ensuring that only quality and safe regulated products are imported, exported, manufactured, distributed, sold, and used,” she added.

The NAFDAC boss further encouraged local manufacturers to intensify efforts to meet global standards. She revealed that NAFDAC had been laying the policy groundwork since 2019, introducing initiatives like the “5+5” regulatory directive. This policy discourages the continued importation of products that can be manufactured locally after an initial five-year registration cycle.

“We discovered during the COVID-19 pandemic how fragile our reliance on imported medical devices can be,” Adeyeye explained. “This prompted us to refocus our strategy and commission evaluations of locally manufactured syringes to assess their performance.”

According to her, NAFDAC’s evaluations, which included field investigations and laboratory testing, showed mixed results for local syringes. While some products met quality standards, others did not. In response, NAFDAC launched a “hand-holding” initiative to guide manufacturers toward international compliance, offering unannounced inspections and technical support.

“The results of these evaluations were shared with manufacturers. With our continued collaboration, we have seen improvements, and today, AFRI Medical is the shining example of what is possible,” she said.

Speaking at the event, AFRI Medical’s General Manager, Mr. Gabi Al-Aridi, described the WHO pre-qualification as a “milestone achievement,” emphasizing that the certification enables the company to supply top-quality syringes to international organizations, including UNICEF.

“This means that AFRI Medical Nigeria can now export syringes with the highest level of WHO certification, as well as ISO and market clearance certifications,” Al-Aridi noted.

Former NAFDAC Director and current staff member of AFRI Medical, Mr. Sheriff Olagunju, also praised the partnership between NAFDAC and AFRI Medical. “It’s been a very tedious journey with WHO and its technical team. But the pre-qualification is proof of AFRI Medical’s competence and commitment to global standards,” he said.

The event was attended by directors from various NAFDAC departments and representatives of AFRI Medical, all of whom echoed the call for increased investment in local medical device manufacturing.

Adeyeye urged other manufacturers to take advantage of NAFDAC’s regulatory support, saying, “We are open to working with any local manufacturer committed to compliance and excellence.”

The WHO pre-qualification of AFRI Medical’s syringes is seen as a significant step towards reducing Nigeria’s reliance on imported medical devices and boosting local manufacturing for global competitiveness.